News by subject: IMA

PTC Therapeutics, Inc. today announced that the Brazilian National Health Surveillance Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved the expansion of the indication of Translarnatm (ataluren) to include ambulatory children...

Cerebral blood flow (CBF), which supplies oxygen and nutrients to our brain, is a crucial indicator of brain health. Information from CBF can, therefore, help us diagnose brain disorders. While this information is usually obtained from speckle...

Appreciated by thousands of readers, Rejuvenate Aging Eyes The Miracle of PIE, has made complex medical jargon a breeze for the everyday person. Explaining procedures that can be scary for patients in simple language, it allows people desiring...

Today, LumiraDx , a next-generation point of care diagnostics testing company announced it has received emergency use...

SHENZHEN CHIPSCREEN BIOSCIENCES CO., LTD. (hereinafter referred to as: CHIPSCREEN), a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform,...

InnoCare Pharma (HKEX: 09969) announced today that the Company has received Investigational New Drug (IND) approval from the NMPA for its SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189, which is the...

Novartis Pharmaceuticals Canada Inc. applauds the government of Quebec's decision to provide public reimbursement for Zolgensma® (onasemnogene abeparvovec) for the treatment of children with SMA....

LEO Pharma Inc. announced today the Health Canada approval of Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic...

Alnylam Pharmaceuticals, Inc.  is pleased to announce that GIVLAARI® (givosiran) has now received a positive recommendation for reimbursement from the Canadian Agency for Drugs and Technologies in Health (CADTH). GIVLAARI® is approved by Health...

Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that Health Canada has approved FERRIPROX® (deferiprone) for the treatment of iron overload...

The Lancet Respiratory Medicine, one of the world's best-known peer-reviewed medical journals has published Medigen Vaccine Biologics (MVC) data from its MVC-COV1901 vaccine phase 2 clinical trial which demonstrates promising immunogenicity and...

The Lancet Respiratory Medicine, one of the world's best-known peer-reviewed medical journals has published Medigen Vaccine Biologics (MVC) data from its MVC-COV1901 vaccine phase 2 clinical trial which demonstrates promising immunogenicity and...

Qilian International Holding Group Limited  (the "Company"), a China-based pharmaceutical and chemical products manufacturer, announced that on September 14, 2021, through its subsidiary Gansu Qilianshan Pharmaceutical Co., Ltd. (the "Gansu QLS"), it...

Subtle Medical, a healthcare technology company improving the quality and efficiency of medical imaging, announced today Health Canada/Santé Canada approval for their suite of AI-powered image enhancement solutions. Subtle's vendor-neutral software,...

Sanofi Canada is pleased to announce that Health Canada has approved SARCLISA® in combination with carfilzomib and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior...

INOVIO , a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that it has received authorization from...

Medtronic plc , the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for the Hugotm robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. CE Mark approval is for...

Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced the filing of an...

Himalaya Therapeutics ("Himalaya"), a clinical-stage biopharmaceutical company focused on development and commercialization in Greater China, of a novel class of investigational antibody therapeutics for the treatment of solid tumor cancer, which are...

The Mitra® microsampling device from US-based Neoteryx is now approved as a Class B in vitro diagnostic (IVD) medical device by the South African Health Products Regulatory Authority (SAHPRA) in South Africa (ZA). Separations, a ZA-based distributor...

Electromedical Technologies, Inc. (the "Company"), a pioneer in the development and production of bioelectronic devices designed to relieve chronic, intractable and acute pains by using frequencies and electro-modulation, is pleased to announce that...

 - Ryaltris® is a fixed dose combination nasal spray that combines an antihistamine (Olopatadine) with a steroid (Mometasone Furoate) for treatment of allergic rhinitis  - Ryaltris® has been well received by the global medical community for the...

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in Germany. The approval applies to the drug Sedaconda (isoflurane) for administration via the medical device AnaConDa...

Medtronic plc , the global leader in medical technology, today announced it has received CE Mark approval for its radial artery access portfolio, which includes the Risttm 079 Radial Access Guide Catheter and Risttm Radial Access Selective Catheter....

Kevin Pereau, TranscendIT Health's Founder and Principal and author of The Digital Health Revolution is back with its sequel, It Takes a Village. The 255-page paperback is now available on Amazon.com (TranscendIT Health). A Kindle eBook is also being...

-  The UK and Germany are the first two European countries where Klisyri® will be available for prescription. The product has been approved for the treatment of actinic keratosis by the UK Medicines and Healthcare products Regulatory Agency (MHRA)...

Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV® (enfortumab vedotin) for radically unresectable...

Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that on September 22 the Brazilian Health Regulatory Agency (ANVISA)...

The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) today announced the Russian single-component Sputnik Light vaccine against coronavirus has been approved by the Egyptian Drug Authority (EDA). Sputnik Light vaccine is based...

Akeso, Inc. (the Company, 9926.HK) announces that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world's first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research...

Akeso, Inc. (the Company, 9926.HK) announces that the National Medical Products Administration (the NMPA) of China has officially accepted the new drug application for the world's first-in-class Cadonilimab (PD-1/CTLA-4 bi-specific antibody, research...

American Jewish Committee (AJC) welcomes the introduction today of a resolution in the U.S. Senate urging the European Union to designate Hezbollah in its entirety as a terror organization. The bipartisan resolution was introduced by Senators Jacky...

Luye Pharma Group today announced that marketing approval for its innovative formulation Rivastigmine Multi-Day Transdermal Patch (Rivastigmine MD) has been granted by the UK's Medicines and Healthcare Products Regulatory Agency, for the treatment of...

SAVVYWIRE, the first guidewire that aims to improve procedural efficiency and clinical outcomes for patients undergoing minimally invasive, Trans Aortic Valve Replacement (TAVR)...

Insightec®, a global healthcare company focused on transforming patient care, announced its incisionless neurosurgery platform, the Exablate® 4000, has received market approval by the Central Drugs Standard Control Organization (CDSCO), part of the...

Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of adults with previously treated,...

Luye Pharma Group has recently been granted official approval by the Saudi Food and Drug Authority to become the Marketing Authorization Holder (MAH) for Seroquel and Seroquel XR in Saudi Arabia. Meanwhile, the new localized packaging for Seroquel...

Pfizer Canada ULC and BioNTech SE today announced that Health Canada has granted full approval (Notice of Compliance or NOC) for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older....

Co-Diagnostics, Inc.  (the "Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that CoSara Diagnostics Pvt Ltd ("CoSara," or the "JV"), its joint venture for...

Diabeloop, created in 2015, deployed its first Automated Insulin Delivery (AID) system throughout Europe this year. The AI-based personalized solution is currently commercialized in Germany, the Netherlands, Italy, Spain and Switzerland, with more...

Amgen today announced that Health Canada has approved LUMAKRASTM (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have...

AUSTRALIAN patients with an...

Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that Brazil's National Health Surveillance Agency (ANVISA) has approved FERRIPROX®...

Yiling Pharmaceutical recently announced that its newly-developed drug Yishen Yangxin Anshen Tablet had been granted official drug certificate by China's National Medical Products Administration (NMPA). With the functions of reinforcing kidney,...

The first CAR-T product independently developed in China and approved as a Category 1 biologics product, and the sixth approved CAR-T product globally Currently the only approved CAR-T product that has been simultaneously included in the National...

The European Medicines Agency has issued a marketing authorisation for OZAWADEtm (pitolisant), indicated in the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea in adults. OZAWADEtm is indicated to improve...

Zymo Research announced today its new line of at-home sample collection kits has received CE marking for sale in the European Union (EU). The SafeCollecttm Sample Collection Kits were designed with consumers' utmost safety in mind for unsupervised...

Sofwave Medical LTD, today announced it has received approval from the Korean Ministry of Foods and Drug Safety (MFDS) to market Sofwavetm its proprietary next-generation Synchronous Ultrasound Parallel Beam technology SUPERBtm for reducing the...

BioMarin Pharmaceutical Inc. announced today that the European Commission (EC) has granted marketing authorization for VOXZOGO® (vosoritide), a once daily injection to treat achondroplasia in children from the age of 2 until growth plates are...

Vertex Pharmaceuticals Incorporated (Canada)  today announced that Health Canada has granted Marketing Authorization for PrKALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) as young as four months of age who have at least one of the...